Anrikefon-based Patient-controlled Intravenous Analgesia After Laparoscopic Surgery (NCT07246785) | Clinical Trial Compass
TerminatedPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia After Laparoscopic Surgery
Stopped: The study was terminated due to substantial protocol amendments involving changes in the target population and primary endpoint, rendering previously collected data incompatible with the revised study objective.
China13 participantsStarted 2025-12-25
Plain-language summary
Visceral pain following laparoscopic surgery is frequently underestimated, yet it is associated with a range of adverse outcomes. Effective visceral pain management should constitute an essential component of postoperative analgesic strategies following laparoscopic procedures. However, conventional analgesic agents, including μ-opioid receptor agonists, lack specificity for visceral pain. Anrikefon, a novel selective peripheral κ-opioid receptor agonist, demonstrates unique efficacy in alleviating visceral pain with a favorable safety profile. Preliminary studies showed that a single intravenous dose of anrikefon effectively alleviates postoperative pain after abdominal surgery with a low risk of adverse effects. The investigators hypothesize that an appropriate dosing regimen of anrikefon administered via patient-controlled intravenous analgesia (PCIA) pump, as part of a multimodal analgesic strategy, can specifically target and alleviate visceral pain after laparoscopic surgery, thereby achieving comprehensive postoperative analgesia.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. Aged ≥ 18 years but \< 75 years;
✓. Scheduled to undergo elective laparoscopic gastrointestinal surgery with an expected duration of ≥1 hour;
✓. The incisional pain can be covered by the transversus abdominis plane block or rectus sheath block; yet patients still require postoperative patient-controlled intravenous analgesia.
Exclusion criteria
✕. Presence of preoperative cognitive impairment (Mini-Mental State Examination \[MMSE\] score \< 27), or inability to communicate due to language barrier;
✕. Body mass index (BMI) \> 30 kg/m² or \< 18 kg/m²;
✕. Presence of poorly controlled or untreated comorbidities, including but not limited to the following: hypertension characterized by a resting systolic blood pressure (SBP) \> 180 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg, coronary artery disease with unstable angina or myocardial infarction within 6 months, heart failure rated as New York Heart Association classification ≥ III, severe chronic obstructive pulmonary disease (or in a state of acute exacerbation), severe hepatic insufficiency (Child-Pugh grade C), severe renal insufficiency (estimated glomerular filtration rate \< 30 ml/min/1.73m²), or American Society of Anesthesiologists (ASA) physical status classification ≥ IV;
What they're measuring
1
Time-weighted sum of pain intensity difference (SPID) of movement-evoked visceral pain within 48 hours
✕. Continuous use of opioid analgesics for more than 10 days for any reason, or alcohol abuse (average daily intake of pure alcohol \> 36 g) within 3 months before screening;
✕. Preoperative use of opioid or non-opioid analgesics with the interval between the last administration and randomization shorter than five half-lives of the drug or the duration of drug action (whichever is longer);
✕. Known allergies or contraindications to opiates or other medications that may be used in this study, such as anesthetics, antiemetics, and nonsteroidal anti-inflammatory drugs (NSAIDs);
✕. Anticipated need for postoperative mechanical ventilation；
✕. Other conditions that are considered unsuitable for study participation.